Use of Acellular Dermal in the Incarcerated Inguinal Hernia Tension-free Reconstructions

Xijing Hospital of Digestive Diseases

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Incarcerated Inguinal Hernia

Treatments: Procedure: ADM tension-free hernia reparation

Study type: Interventional

Funder types: Other

Identifiers

NCT02469142

ADM001

Details and patient eligibility

About

Incarcerated inguinal hernia is one of the common acute abdomen abdominal surgery, often prone to intestinal necrosis and acute peritonitis.Using traditional tension hernia reparation, the recurrence rate were as high as 30%. In recent years, biological materials especially acellular matrix materials (Acellular Dermal Matrix, ADM) in resisting the infection, has become a research hotspot. In the project, the investigators try to address the role of ADM in incarcerated inguinal hernia patients.

Full description

observation indicator:

1. recurrence rate after operation
2. incidence rate of complications
3. postoperative hospital stay
4. hospitalization costs
5. Self-evaluation of gastroesophageal reflux symptoms and quality of life(QOL) in 6th-month, 1st-year,2nd-year,3rd-year,4th-year and 5th-year after operation

Enrollment: 100 estimated patients

Sex: All

Ages: 16 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of incarcerated hernia
• randomly select patch agreed by patients and family members

Exclusion criteria

• severe organ dysfunction
• No-tolerate anesthesia
• No-suitable for operation
• glucocorticoid with long-term use
• Sever intraperitoneal adhesion existed
• spirit disease patients
• automatically exit

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups, including a placebo group

ADM tension-free hernia reparation

Experimental group

Description:

Use ADM to repair incarcerated inguinal hernia by tension-free

Treatment:

Procedure: ADM tension-free hernia reparation

traditional tension hernia reparation

Placebo Comparator group

Description:

Just repair incarcerated inguinal hernia by nothing in tension condition